MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00513840
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat an esophageal cancer during a stent placement procedure performed on (b)(6) 2021.The patient's anatomy was dilated prior to stent placement.During the procedure, the stent delivery system could not cross the lesion.The stent was removed and a wallflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the stent was partially deployed.
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).An ultraflex esophageal ng proximal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent was partially deployed.The shaft was returned bent.Functional evaluation was performed and the stent was able to be deployed by holding the delivery catheter stationary with one hand and grasping the finger ring attached to the handle with the other hand and gently pulled the finger ring to release the stent.No other problems were noted to the stent and delivery system.The reported event of delivery system difficult to cross lesion occurred during the procedure and could not be functionally/visually verified.The damages observed of the returned device were most likely due to procedural or anatomical factors encountered during the procedure.Handling and manipulation of the device during the procedure could lead to the bent shaft, difficultly of the device crossing the lesion and the partially deployed stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13020825
• Report Number: 3005099803-2021-07753
• Device Sequence Number: 14608834
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0025347881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male